Intersurgical Medical Apparatus (Changzhou) Co., Ltd. FDA Record
- Latest inspection VAI · Aug 28, 2025
- No warning letters matched by name
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Intersurgical Medical Apparatus (Changzhou) Co., Ltd." is on file.
- Latest inspection
- Aug 28, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 28, 2025 | Changzhou, China | Devices | Voluntary Action Indicated (VAI) | 3015168843 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3015168843 | Changzhou, China | 1 | Aug 28, 2025 |
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. and the FDA: common questions
Has Intersurgical Medical Apparatus (Changzhou) Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Intersurgical Medical Apparatus (Changzhou) Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Intersurgical Medical Apparatus (Changzhou) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Intersurgical Medical Apparatus (Changzhou) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Intersurgical Medical Apparatus (Changzhou) Co., Ltd.?
The most recent FDA inspection on file ended Aug 28, 2025 at Changzhou, China and was classified VAI. FDA has 1 inspection of Intersurgical Medical Apparatus (Changzhou) Co., Ltd. on file.
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